Neuroprotective Effect of Neurotropin on Chronic OXA-induced Neurotoxicity in Stage II and Stage III CRC Patients

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Other: Placebo; Drug: Neurotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT07320950

B2020-061-01

Details and patient eligibility

About

Oxaliplatin is effective in adjuvant and first-line colorectal cancer chemotherapy. Oxaliplatin-induced severe chronic neurotoxicity is the main dose-limiting adverse event. No standard treatment for oxaliplatin-induced chronic toxicity has been defined. Neurotropin has been identified as a strategy for reducing the peripheral neurotoxicity in the published studies. Our aim is to define the best intake dose and evaluate the safety of neurotropin for peripheral neurotoxicity of oxaliplatin by conducting a placebo-controlled clinical trial.

Enrollment: 333 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 75 years old
• Stage II or III colorectal cancer patients confirmed by pathological diagnosis, and recovered from surgery within 8 weeks
• should receive adjuvant chemotherapy especially XELOX regimen after assessment by physicians and specialists
• Agreed and assigned the consent, and was able to receive the baseline assessment
• Could be inpatient or outpatient participants

Exclusion criteria

• Peripheral neuropathy patients, e.g. diabetes neuropathy
• Alcoholic related patients
• Central neuropathy patients
• Patients who were unable to assess the effectivity and safety
• Neurotropin allergy
• History of medications that are contraindicated to neurotropin <28 days before the trial begins
• Have already received neurotropin tablets more than 4 tablets or 3.6 units <4 weeks before the trials begins
• Unable to visit the hospital regularly
• Has been ruled out by investigators
• Brain tumor or metastasis
• Brain injury, stroke and brain hemorrhage symptoms occurred during 6 months after sign the consent
• History of epilepsy, convulsion
• Severe respiratory, cardiovascular, renal, hepatic or hematologic system(except cancer) disease
• Depression and other psychologic conditions which investigators recognized as high risk for the enrollment
• Chronic pain
• Received other medication from other clinical trials within 28 days
• Prepare for pregnancy, pregnant, or lactated women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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333 participants in 3 patient groups, including a placebo group

Neurotropin 4 tablets/day

Experimental group

Description:

All the patients in this group received neurotropin 4 tablets a day ( 2 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Treatment:

Drug: Neurotropin

Neurotropin 8 tablets/day

Experimental group

Description:

All the patients in this group received neurotropin 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Treatment:

Drug: Neurotropin

Placebo

Placebo Comparator group

Description:

All the patients in this group received placebo 8 tablets a day ( 4 tablets once , twice a day, p.o.) ,given for 21 days (day 1-21) while the patient receiving the Oxaliplatin chemotherapy regimen from day1 to day 21 each cycle, totally for 8 cycles.

Treatment:

Other: Placebo